Antiulcer herbal composition(s)

ABSTRACT

The invention provides a novel herbal synergistic formulation for treatment of acute and chronic ulcers in stomach. Formulation(s) comprises of plant extracts together with the conventional additives to form the oral dosage forms which include tablets, capsules and powders ready for suspension.  Utleria solicifolia  along with this plants used traditionally like  Asparagus racemosus, Foeniculum vulgare , and  Ficus glomerata  are added which are used in intestinal discomforts and as an galactogogue.

TECHNICAL FIELD

[0001] The present invention relates to development of an antiulcerherbal composition(s), process of preparing the extracts useful forpreparing herbal formulation to treat ulcers.

BACKGROUND ART

[0002] Peptic ulcer represents a major health problem, both in terms ofmorbidity and mortality. Research advances during the last decade haveoffered new insights in the therapy and prevention of gastroduodenalulceration by measures directed at strengthening the mucosal defensesystem rather than by attenuating the aggressive acid-pepsin factorsheld responsible for the induction of ulcers. The rise in gastricacidity and peptic activity are usually a manifestation of aphysiological disturbance affecting one or more mechanisms whichnormally regulate gastric secretion. Neurotransmitters or hormones thatdirectly stimulate secretion of hydrochloric acid and pepsin by thegastric glands are acetylcholine, gastrin and histamine. In additionthere are other factors which play an important role in themanifestation of peptic ulcers. Activity of the gastric secretary cellshas been found to be stimulated by caffeine, alcohol, hydrochloric acid,sodium chloride, non steroidal anti-inflammatory drugs (NSAIDS) andstress^(3,4,5).

[0003] The recent daily life is called a stress age and the chances ofreceiving stress have been increased by the kaleidoscopic change of theliving environment and the increase of the complexity of personalrelations. Also, the chance of taking many virtual, which do not existin nature has been increased².

[0004] Thus, the number of persons suffering from a stomach ulcer, aduodenal ulcer, etc., by these factors has been increased and variousantiulcer agents have been developed and utilized at present. Theantiulcer agents which have been used at present are largely classifiedinto a digestive power depressant, a gastric juice secretion depressant,a mucous membrane protective tissue reparative agent, etc., and areorally or subcutaneously administered. However, these preparations areisolated medicaments or synthesized medicaments, each medicament haseach side effects, whereby the restrictions about the applicable objectsand the using amount become severe, and an effective and safe antiulceragent has not yet been developed and utilized¹.

[0005] Thus, since these conventional antiulcer agents can not beregularly used from the point of the safety, they can not be utilizedfor the prophylaxis and the recurrence prevention. On the other hand, aspreventives for ulcer, medicines for intestinal disorders andmedicaments having the secretion preventing effect of gastric juice onlyare used and hence, they are not said to be preventives for a ulcer intrue meaning. At present, side effects of medicaments to a human beingbecome a problem and hence the development of a medicament having anantiulcer effect, which is a natural product, gives no side effects, andis sufficiently safe even when the medicament is regularly used as apreventive or a recurring preventing agent has been required^(1,2).

[0006] Hitherto only on oral tradition of Malasar and Kadar tribes ofKerala use Utleria solifolia for treatment of intestinal ailments likecolic and bleeding in stomach. The synthetic conventional drugs eitherinhibit acid secretion or cure the ulcer. The long term treatment of thepresent synthetic drugs completely inhibits the acid and pepsinsecretion which is normally responsible for digestion and function ofstomach and causes cancer. The offensive acid, pepsin and defensivemucin of the stomach plays a critical role in stomach function. TheHelicobacter pylori bacteria, offensive acid, pepsin, consumption of hotfood disrupts the continuity of the cells and leads to ulcer and gastriccancer, yet there is no complete cure. Therefore for the treatment ofacute gastric/duodenal ulcer, and H. pylori, a novel herbal formulationis required. Accordingly studies were undertaken to develop a oralformulation containing herbal drugs along with additives for oralingestion^(6,7) to treat acute gastric/duodenal ulcer and also to treatinternal bleeding.

OBJECTS OF THE INVENTION

[0007] The main object of the present invention to provide a novelanti-ulcer herbal formulation useful for the treatment of acute andchronic ulcers of stomach and duodenum.

[0008] Another objective of the present invention is to prepare herbalformulation(s) that gives immediate relieves the acidity of the stomachby neutralizing the excess acid.

[0009] Yet another object of the present invention is to prepare herbalformulation(s) with a combination of the plants which are used indiarrhea, intestinal discomforts and antimicrobial.

SUMMARY OF THE INVENTION

[0010] Accordingly, the present invention provides a herbal formulationuseful in the treatment of acute and chronic ulcers in stomach. Theherbal formulation comprising of Utleria solifolia that has been used byMalasar and Kadar tribes, Kerala as mentioned in prior art for the abovementioned purpose as the active ingredient. Along with this plants usedtraditionally like Asparagus racemosus, Foeniculum vulgare, and Ficusglomerata are added which are used in intestinal discomforts and as angalactogogue together with conventional additives.

DETAILED DESCRIPTION OF THE INVENTION

[0011] Accordingly, the present invention provides a novel anti-ulcerherbal synergistic formulation useful for the treatment of acute andchronic ulcers of stomach and duodenum, said formulation comprising:

[0012] a) 50% aqueous alcoholic extracts of the plants comprisingUtlaria solicifolia 2-5 wt. %, Asparagus racemnosus 1-3 wt. %,Foeniculum vulgare 2-4 wt. %, and Ficus glomerata 3-5 wt. % in an oraldosage form selected from a group consisting of a tablet, a capsule, apowder and a liquid.

[0013] The novelty of the present investigation is (1) herbalformulation for the treatment of gastric and duodenal ulcers (2) theherbal formulation neutralizes the excess acid in the stomach (3) theherbal formulation is useful in healing and curing of ulcers (4) unlikethe commercial antiulcer agents, the herbal formulation also checks theinternal bleeding.

[0014] In an embodiment, the plant extracts used may be Utlariasolicifolia, Asparagus racemosus, Foeniculum vulgare, and Ficusglomerata.

[0015] In still another embodiment, the formulation may be made intotablet, capsule or powder ready for suspension.

[0016] In yet another embodiment, the binder used may be either starchor gum acacia or carboxymethyl cellulose

[0017] In still another embodiment, the diluent used to make up thedosage form may be lactose.

[0018] In another embodiment, the extracts of plants used are 50%aqueous alcoholic extracts.

[0019] In another embodiment, alcohol used is ethanol.

[0020] In still another embodiment, formulation(s) treats stomachdiscomforts, gastric cancer, stomachache, intestinal discomforts,gastric and duodenal ulcers.

[0021] In yet another embodiment, the extracts of the plants are mixedin the ratio Utlaria solicifolia 2-5 wt. %, Asparagus racemosus 1-3 wt.%, Foeniculum vulgare 2-4 wt. %, and Ficus glomerata 3-5 wt. % alongwith conventional additives to form oral solid dosage forms.

[0022] In another embodiment, formulation(s) comprises about 8-17% wt ofthe total formulation.

[0023] In still another embodiment, extract of Utlaria solicifolial is arhizome extract.

[0024] In yet another embodiment, the plant extracts are obtained: fromplant parts selected from leaf, rhizome and aerial parts.

[0025] In still another embodiment, the lubricants used are from starchand lactose.

[0026] In an embodiment, the formulation is used in treating diarrhea,intestinal discomforts and is an antimicrobial agent.

[0027] In another embodiment, the formulation immediately relieves theacidity of the stomach by neutralizing the excess acid.

[0028] In another embodiment, the formulation at a dose of 100 to 200mg/kg in cold restraint stress induced ulcers gives an ulcer index of11.2±3.1 to 4.2±1.0

[0029] In yet another embodiment, the formulation at a dose of 100 to200 mg/kg in cold restraint stress induced ulcers gives an % curativeratio of 83.59 to 56.25.

[0030] In still another embodiment, the formulation at a dose of 100 to200 mg/kg in pylorus ligation induced ulcers gives an ulcer index of6.1±0.8 to 4.8±1.2.

[0031] In another embodiment, the formulation at a dose of 100 to 200mg/kg in pylorus ligation induced ulcers gives an % curative ratio of57.93 to 66.90.

[0032] In yet another embodiment, the formulation at a dose of 100 to200 mg/kg showed lipid peroxidation capacity in rat gastric mucosa of0.1±0.01 to 0.21±0.01.

[0033] In still another embodiment, the formulation at a dose of 100 to200 mg/kg in ethanol induced changes in gastric ulcers of 64.94 to86.75% protection and significant increase in gastric wall mucus inrats.

[0034] In yet another embodiment, the formulation at a dose of 100 to200 mg/kg in aspirin induced changes in gastric ulcers in rats showed anulcer index of 7.1±2.2 to 6.2±1.3 and % curative ratio of 61.41 to66.30.

[0035] In still another embodiment, the formulation at a dose of 100 to200 mg/kg in acetic acid induced (ulcer healing) chronic ulcers in ratsshowed 2.1 to 0.0% incidence of perforations and 31.2 in control.

[0036] As a result of intensive study conducted by the inventors withthe aim of achieving aforementioned objectives, new formulations fororal ingestion were developed employing herbal drugs which are fromnatural origin, incorporating them into binders and diluents to formoral dosage forms.

[0037] Accordingly, the present investigation deals with the oral dosageform formulation(s). Each formulation has been described in detailgiving the formula of the ingredients along with the method ofpreparation. These examples are for illustration only and should not beconstrued to limit the scope of the invention.

[0038] The first step in the preparation of these formulations involvesa process for making, the plant material suitable for formulating into atablet/capsule. The specified portion of the plant is collected anddried under shade at room temperature (25-35° C.) for 72 hours or untilthe material gets dried. The material is then powdered into a finepowdered. A specified amount of the powdered material is then extractedexhaustively with 50% aqueous alcohol at room temperature (25-35° C.).Extraction was carried out in a closed container immersing specifiedamount of the plant material in specified solvent (1:8-1:15 ratio) for4-7 days. At the end of this stage, solvent is decanted and filtered ifnecessary to make it free from plant debris. The solvent is thenconcentrated by evaporating under vacuum at less than 40-60° C. Theconcentrate is then freeze dried to obtain final product in powder form.The final product is then made into oral dosage form by using it as aningredient for making tablets and capsules. Suitable binders like starchand diluents like lactose are added to make up the formulation.

EXAMPLE 1

[0039] Utlaria solicifolia  3 wt. % Asparagus racemosus  2 wt. %Foeniculum vulgare  3 wt. % Ficus glomerata  3 wt. % Starch paste 15 wt.% Talc  1 wt. % Lactose q.s. to make 100%

[0040]Utlaria solicifolia, Asparagus racemosus, Foeniculum vulgare,Ficus glomerata were collected and dried in shade. The dried material (1Kg) is then powdered and extracted with 50% aqueous alcohol (3 L) for 5days. At the end of this, the solvent is decanted and filtered ifnecessary to remove the plant debris. The extract is then concentratedunder vacuum at less than 50° C. Then the extract is lyophilized toobtain the extract in powder form.

[0041] 15 g of starch is mixed with water and heated to form a paste.The weighed quantities of the plant extracts are then blended withstarch paste and then lactose is added quantity sufficient to make 100g. The ingredients are then mixed properly with the starch paste to forma mass. The mass is then granulated in a granulator and then the dry at104° F. and screen through 16 mesh screen. Talc is added to the driedgranules and then they are punched in the tablet-punching machine toform uniform tablets. The formulation is useful for the treatment ofacute and chronic gastric and duodenal ulcers and internal bleeding

EXAMPLE 2

[0042] Utlaria solicifolia 2 wt. % Asparagus racemosus 1 wt. %Foeniculum vulgare 4 wt. % Ficus glomerata 4 wt. % Lactose q.s to make100%

[0043]Utlaria solicifolia, Asparagus racemosus, Foeniculum vulgare,Ficus glomerata were collected and dried in shade. The dried material (1Kg) is then powdered and extracted with 50% aqueous alcohol (3 L) for 5days. At the end of this, the solvent is decanted and filtered ifnecessary to remove the plant debris. The extract is then concentratedunder vacuum at less than 50° C. Then the extract is lyophilized toobtain the extract in powder form. The weighed quantities of the plantextracts as mentioned are mixed with the diluent lactose and then arefilled in hard gelatin capsules and are dispensed.

[0044] The formulation is useful for the treatment of acute and chronicgastric and duodenal ulcers and internal bleeding

[0045] Procedures for antiulcer activity screening:

[0046] 1. Ethanol induced ulcers: The gastric ulcers were induced inrats by administering ethanol (1 ml/200 g, 1 h) and the animals weresacrificed by cervical dislocation and stomach was incised along thegreater curvature and examined for ulcers.

[0047] 2. Aspirin induced ulcers: Aspirin in dose of 200 mg/kg wasadministered to the animals and ulcers were scored after 4 hours. Thestomach was taken out and cut open along with greater curvature and theulcers were scored by a person unaware of experimental protocol in theglandular portion of the stomach.

[0048] 3. Cold restraint stress—induced ulcers: Rats were strapped on awooden plank and kept them at 4-6° C. for 2 hours. The animals were thensacrificed by cervical dislocation and ulcers were scored on thedissected stomach.

[0049] 4. Pylorus ligated induced ulcers: Animals were anaesthetizedusing pentobarbitione (35 mg/kg, i.p.), the abdomen was opened andpylorus ligation was done without causing any damage to its bloodsupply. The stomach was replaced carefully and the abdomen wall wasclosed in 2 layers with interrupted sutures. The animals were deprivedof water during postoperative period. After 4 hours stomach weredissected out and contents were collected and ulcer index wascalculated.

[0050] 5. Acetic acid induced ulcers: The rats were anaesthetized withpentobarbitone (35 mg/kg, i.p.). The abdomen was opened and the stomachwas visualized. Cylindrical glass tube of 6 mm diameter was tightlyplaced upon the anterior serosal surface of the glandular portion on thestomach 1 cm away from the pyloric end. 50% acetic acid (0.06 ml/animal)was instilled into the tube and allowed to remain 60 s on the gastricwall. After removal of the acid solution, the abdomen was closed in 2layers and animals were caged and fed normnally.

[0051] The animals were sacrificed after the last dose of treatmenteither on 6^(th) or 11^(th) of day of experiment to assess the ulcersize healing. Ulcer index was calculated based upon the product oflength and width (mm²/rat) of ulcers.

[0052] 6. Cysteamine induced duodenal ulcers: Cysteamine in 2 doses of400 mg/Kg of 4 intervals time were administered to induce duodenalulcers. The animals were sacrificed after drug treatment and observedfor the presence or absence of ulcers. TABLE 1 Effect of antiulcerHerbal composition (HC₁) and formulation without Utlaria solicifolia(HC₂) on cold restraint stress (CRS) and pylorus ligation (PL) - inducedchanges in gastric ulcers in rats. CRS - induced ulcers PL - inducedulcers % % Curative Ulcer Curative Treatment Dose Ulcer Index RatioIndex Ratio Control — 25.6 ± 4.2 — 14.5 ± 2.5 — HC₁ 100 11.2 ± 3.1^(a)56.25  6.1 ± 0.8^(b) 57.93 HC₁ 200  4.2 ± 1.0^(c) 83.59  4.8 ± 1.2^(b)66.90 HC₂ 100 17.2 ± 3.1 32.81 10.5 ± 2.8 27.59 HC₂ 200 13.3 ± 4.5 48.05 7.8 ± 1.6^(a) 46.21 Ranitidine  50  5.2 ± 1.1^(c) 79.68  5.1 ± 1.3^(b)64.82

[0053] NOTE:

[0054] No mortality was found in any of the treated group.

[0055] No gross abnormality in behavior was observed in the animalexposed with HC₁ herbal preparation.

[0056] HC₁ showed dose dependent and significant (P: ^(a)<0.05 to P:^(a)<0.001) ulcer protective effect ranged 56.25-83.59%. The H₂ receptorblocker ranitidine showed significant protection and % protection (64.82and 79.68%) in CRS and pylorus ligation induced ulcers.

EXAMPLE 3

[0057] Utlaria solicifolia   4 wt. % Asparagus racemosus   2 wt. %Foeniculum vulgare   3 wt. % Ficus glomerata   3 wt. % Sodiumbicarbonate 0.5 wt. % Citric acid 0.5 wt. % Lactose q.s to make 100%

[0058]Utlaria solicifolia, Asparagus racemosus, Foeniculum vulgare,Ficus glomerata were collected and dried in shade. The dried material (1Kg) is then powdered and extracted with 50% aqueous alcohol (3 L) for 5days. At the end of this, the solvent is decanted and filtered ifnecessary to remove the plant debris. The extract is then concentratedunder vacuum at less than 50° C. Then the extract is lyophilized toobtain the extract in powder form. The extracts of the plants are mixedwith sodium bicarbonate, and citric acid. It is then dry granulated,sieved and punched to form effervescent tablets.

[0059] The formulation is useful for the treatment of acute and chronicgastric and duodenal ulcers and internal bleeding

EXAMPLE 4

[0060] Asparagus racemosus   2 wt. % Foeniculum vulgare   4 wt. % Ficusglomerata   4 wt. % Starch paste  15 wt. % Talc 1.5 wt. % Lactose q.s.to make 100%

[0061]Asparagus racemosus, Foeniculum vulgare, Ficus glomerata werecollected and dried in shade. The dried material (1 Kg) is then powderedand extracted with 50% aqueous alcohol (3 L) for 5 days. At the end ofthis, the solvent is decanted and filtered if necessary to remove theplant debris. The extract is then concentrated under vacuum at less than50° C. Then the extract is lyophilized to obtain the extract in powderform. 15 g of starch is mixed with water and heated to form a paste. Theweighed quantities of the plant extracts are then blended with starchpaste and then lactose is added quantity sufficient to make 100 g. Theingredients are then mixed properly with the starch paste to form amass. The mass is then granulated in a granulator and then the dry at104° F. and 1screen through 16-mesh screen. Talc is added to the driedgranules and then they are punched in the tablet-punching machine toform uniform tablets.

[0062] The formulation is useful for the treatment of acute ulcers. Incase of HC2 formulation (without Ulteria solicifolia) the significant(P<0.05) ulcer protection observed at 200 mg/Kg in Pylorus inducedulcers only.

Advantages

[0063] 1. Neutralizes the excess acid in the stomach.

[0064] 2. Used in acute and chronic gastric/duodenal ulcers.

[0065] 3. Used in healing and curing of ulcers.

[0066] 4. Useful in curing internal bleeding.

References Cited

[0067] US Patents 6,187,313 February 2001 Segelman 5,728,384 March 1998Tokuyama

[0068] Other Documents

[0069] Sairam et al. J. Ethnopharmacology. 82 pp. 1-9, 2002.

[0070] Sairam et al. Phytomedicine, 86 (6), pp. 423-430, 2001.

[0071] Raw et al. Indian J. Physiol. Pharmacol, 44(4), pp. 435-441,2000.

[0072] Remington, The science and practice of pharmacy, 19 ^(th)edition, Vol II. pp. 1635, 1995 Anonymous. Indian Pharmacopoeia. Govt ofIndia, 1996.

1. An antiulcer synergistic herbal formulation, the said formulationcomprising of: INGREDIENTS wt./wt. % a) an extract of Utlariasolicifolia  2 to 5 b) an extract of Asparagus racemosus  1 to 3 c) anextract of Foeniculum vulgare  2 to 4 d) an extract of Ficus glomerata 3 to 5 and e) pharmaceutically acceptable excipient 83 to 92


2. A formulation(s) as claimed in claim 1 can be administered orally inthe form of a tablet, capsule, powder or liquid.
 3. A formulation ofclaim 1, wherein the extract of plants used is obtained by extractingwith 50% aqueous alcoholic solution.
 4. A formulation of claim 3,wherein the alcohol used is ethanol.
 5. A formulation of claim 1,wherein the total wt % of the plant extracts used ranges between 8 and17 of the total formulation.
 6. The formulation of claim 1, wherein theextract of Utlaria solicifolia is a rhizome extract.
 7. A formulation ofclaim 1, wherein the plant extracts used may be obtained from the plantparts selected from leaf, rhizome or aerial parts.
 8. A formulation ofclaim 1, wherein the pharmaceutically acceptable excipient used isselected from binder, diluent, lubricant, glidant, disintegrant orcombinations thereof.
 9. A formulation of claim 8, wherein the diluentsare lactose, starches, sugars such as mannitol, sorbitol, xylitol,dextrose, sucrose, microcrystalline cellulose, basic calcium phosphate,calcium sulfate and mixtures thereof.
 10. A formulation of claim 8,wherein the binders used are starch paste, sorbitol, alginates,polyvinyl pyrrolidone, gum acacia, cellulose derivatives such ashydroxypropylmethyl cellulose, hydroxypropyl cellulose, methylcellulose, carboxymethyl cellulose, methylcellulose, ethylcellulose,pregelatinized starch, or mixtures thereof.
 11. A formulation of claim8, wherein the glidants used are silica derivatives, talc, starch andmixtures thereof.
 12. A formulation of claim 8, wherein the lubricantsused are metallic stearates, stearic acid, talc, polyethylene glycols,soluble salts such as sodium chloride, sodium benzoate, sodium laurylsulfate, spray dried magnesium lauryl sulfate, boric acid, starch,lactose or mixtures thereof.
 13. A method of preparing formulation ofclaim 1, wherein the said method comprises steps of: a) obtaining therequired part of medicinal plants, b) drying the plant material of step(a) in shade, c) powdering the dried plant material of step (b) toobtain a coarse plant powder, d) extracting the powdered plant materialof step (c) with aqueous ethanol at a temperature range of 25-35° C. fora time period of 4 to 7 days to obtain an aqueous alcoholic extract, e)concentrating the obtained extract of step (d) under reduced pressure ata temperature range of 40-60° C. to obtain a concentrated extract, f)lyophilising the concentrated extract of step (e) for complete removalof solvent to obtain the required plant extract, and g) mixing andformulating the plant extract of step (f) with suitable pharmaceuticallyacceptable excipient to obtain the required formulation.
 14. A method ofclaim 13, wherein in step (a) the medicinal plant are used from Utlariasolicifolia, Asparagus racemosus, Foeniculum vulgare, and Ficusglomerata.
 15. A method of claim 14, wherein the parts of the medicinalplant used is selected from leaf, rhizome or aerial parts.
 16. A methodof claim 13, wherein in step (d) the aqeuous ethanol used containswater:ethanol in the ratio of 6:4 to 1:1.
 17. A method of claim 13,wherein in step (d) the ratio of plant and aqeuous ethanol used is inthe range of 1:8 to 1:15.
 18. A method of claim 13, wherein the totalplant extracts used ranges between 8 to 7 wt. % of the totalformulation.
 19. A method of claim 13, wherein the pharmaceuticallyacceptable excipients are selected from a group consisting of binder,diluent, lubricant, glidant, disintegrant or mixtures thereof.
 20. Amethod of claim 19, wherein the diluents are lactose, starches, sugarssuch as mannitol, sorbitol, xylitol, dextrose, sucrose, microcrystallinecellulose, basic calcium phosphate, calcium sulfate and mixturesthereof.
 21. A method of claim 19, wherein the binders used are starchpaste, sorbitol, alginates, polyvinyl pyrrolidone, gum acacia, cellulosederivatives such as hydroxypropylmethyl cellulose, hydroxypropylcellulose, methyl cellulose, carboxymethyl cellulose, methylcellulose,ethylcellulose, pregelatinized starch, or mixtures thereof.
 22. A methodof claim 19, wherein the glidants used is silica derivatives, talc,starch or mixtures thereof.
 23. A method of claim 19, wherein thelubricants used are metallic stearates, stearic acid, talc, polyethyleneglycols, soluble salts such as sodium chloride, sodium benzoate, sodiumlauryl sulfate, spray dried magnesium lauryl sulfate, boric acid,starch, lactose or mixtures thereof.
 24. Use of formulation of claim 1for relieving the acidity of the stomach by neutralizing the excessacid.
 25. Use of formulation of claim 1 to treat stomach disomforts,gastric cancer, stomachache, intestinal discomfort, gastric ulcer,duodenal ulcer and diarrheoa.
 26. Use of formulation of claim 1 as anantimicrobial agent.
 27. Use of formulation of claim 1 at a dose of 100to 200 mg/kg in cold restraint stress induced ulcers having an ulcerindex in the range of 11.2±3.1 to 4.2±1.0.
 28. Use of formulation ofclaim 1 at a dose of 100 to 200 mg/kg in cold restraint stress inducedulcers having a percentage curative ratio of 83.59:56.25.
 29. Use offormulation of claim 1 at a dose of 100 to 200 mg/kg in pylorus ligationinduced ulcer having an ulcer index in the range of 6.1±0.8 to 4.8±1.230. Use of formulation(s) of claim 1, at a dose of 100 to 200 mg/kg inpylorus ligation induced ulcer gives a percentage curative ratio of57.93:66.90.
 31. Use of formulation of claim 1 at a dose of 100 to 200mg/kg showed lipid peroxidation capacity in rat gastric mucosa in therange of 0.1±0.01 to 0.21±0.01.
 32. Use of formulation of claim 1 at adose of 100 to 200 mg/kg in an ethanol induced gastric ulcers, provides64.94 to 86.75% protection and significant increase in gastric wallmucus in rats.
 33. Use of formulation of claim 1 at a dose of 100 to 200mg/kg in aspirin induced gastric ulcers in rats, showed an ulcer indexof 7.1+2.2 to 6.2+1.3 and %curative ratio of 61.41 to 66.30.
 34. Use offormulation of claim 1 at a dose of 100 to 200 mg/kg in acetic acidinduced chronic ulcer healing in rats showed 0.0 to 2.1% incidence ofperforations in comparison to 31.2% in control.
 35. Use of formulationof claim 1 at a dose of 100 to 200 mg/kg in cysteamine induced duodenalulcers in rats showed 0 to 20% incidence when compared to 80% incidenceof ulcers in control.